Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 3, 2019

Primary Completion Date

April 1, 2025

Study Completion Date

April 1, 2025

Conditions
ANCA Associated Vasculitis
Interventions
DRUG

Rituximab

Patients will be intravenously treated with Rituximab 1000mg (or biosimilar) in the first week and receive a 2nd dosage of 1000mg 14 days later. Before every infusion of Rituximab patients will receive intravenous methylprednisolone 100mg together with oral acetaminophen 1000 mg and and intravenous Tavegil 2 mg. At any time during the study, a rituximab biosimilar is allowed as a substitute for the bio-originator rituximab.

DRUG

endoxan

Patients will be intravenously treated with a total of 6 infusions of cyclophosphamide 500mg every 2 weeks. Before every infusion of cyclophosphamide patients will receive intravenous granisetron to prevent nausea.

DRUG

Methylprednisolone

Patients are given 1-3 pulses of 500mg methylprednisolone i.v. up to a maximum cumulative dose of 3000mg, taking into account any doses of intravenous methylprednisolone administered within 12 weeks prior to screening.

DRUG

Prednisolone

after intravenous pulse methylprednisolone, oral prednisolone will be given at a dose of 1mg/kg daily and tapered according to the recommendations

Trial Locations (4)

2333ZA

RECRUITING

Leiden University Medical Center, Leiden

Unknown

NOT_YET_RECRUITING

Noordwest Ziekenhuisgroep, Alkmaar

RECRUITING

Meander Medical Center, Amersfoort

NOT_YET_RECRUITING

HagaZiekenhuis, The Hague

All Listed Sponsors
lead

Leiden University Medical Center

OTHER